MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-05-20 for POLIDENT OVERNIGHT DENTURE CLEANSER * manufactured by Glaxosmithkline.
[421977]
Follow up information was received in 2005 in the form medical records. The patient underwent esophagogastroduodenoscopy in 2005, due to complaints of dysphagia. The patient was diagnosed with gastric polypop and underwent a polypectomy and severely ulcereted mucosa under the epiglotis was noted. A moderate size histal hernia was notede and no helicobacter pylori was noted. The patient was treated with protinix. The patient was also diagnosed with severe inflammation of the posterior pharynx and vocal chords and was referred to see an ent specialist.
Patient Sequence No: 1, Text Type: D, B5
[430341]
Follow-up info wad received in 2005 in the form of med records. The pt inderwent an esophagogastroduodenoscopy in 2005 due to complaints of dysphagia. Pt was diagnosed with a gastric polyp and underwent a polypectomy and severely ulcerated mucosa under the epiglottis was noted. A moderate size hiatal hermia was noted and no helicobacter pylori was noted. The pt was treated with protonix. He was also diagnosed with severe inflammation of the posterior pharynx nd vocal cords and was referred to see an ent specialist. Accidental exposure, drug administration error, pheumonia, vomiting, throat irritation, regurgitation of food, speech disorder, malaise, blood pressure increased, body temperture increased, pharyngolaryngeal pain, dysphonia, eating disorder, hiatus hernia, dysphagia, gastric polyps, pharyngitis, vocal cord inflammation, ulcerative lesion.
Patient Sequence No: 1, Text Type: D, B5
[15006262]
Pt reported that pt is "sweating it out" because their doctors informed them that it would be another month before pt gets their voice back, although the consumer was able to speak. Although the consumer consented to provide medical records, none have been received.
Patient Sequence No: 1, Text Type: D, B5
[19260607]
In 2005 the pt accidentally ingested part of a polident (dental) tablet after mistaking it for a piece of hard tack candy and the pt experienced feeling unwell, vomiting for 30 minutes, throat burning, regurgitation after drinking water, and difficulty talking for long periods due to the throat burning. The pt was admitted to the hosp the next day and experienced an elevated blood pressure, a rise in temperature, their throat was raw, their voice raspy and pt had difficulty eating. The pt was diagnosed with an unspecified pneumonia and treated with intravenous antibiotics, potassium salt (potassium) and a liquid diet. The pt was discharged on 22 april 2005 and was given no discharge medications or instruction. The pt's elevation in blood pressure and temperature, throat burning feeling, throat rawness, regurgitation and difficulty eating have resolved. The pt voice remains raspy and the pt reported that the physician stated his voice could remain raspy for months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2005-00005 |
| MDR Report Key | 606199 |
| Report Source | 04 |
| Date Received | 2005-05-20 |
| Date of Report | 2005-05-20 |
| Date of Event | 2005-04-12 |
| Date Mfgr Received | 2005-04-22 |
| Device Manufacturer Date | 2004-11-01 |
| Date Added to Maude | 2005-05-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1500 LITTLETON RD. |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9738892494 |
| Manufacturer G1 | MEMPHIS FACILITY |
| Manufacturer Street | 2149 HARBOR AVE. |
| Manufacturer City | MEMPHIS TN 36113 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 36113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLIDENT OVERNIGHT DENTURE CLEANSER |
| Generic Name | DENTURE CLEANSER |
| Product Code | JER |
| Date Received | 2005-05-20 |
| Returned To Mfg | 2005-05-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | MK304 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 595982 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2005-05-20 |